MAUDE Adverse Event Report: CARLSMED, INC. APREVO; SPINAL INTERBODY INSERTER

Catalog Number	1300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The neck of the locking knob used to lock the implant in the insertion position broke during impaction allowing the implant to become unlocked from the insertion position.This would allow the implant to move into the articulating position.No harm to patient reported.
Additional Manufacturer Narrative
This report is submitted in accordance with the provisions of 21 cfr part 803.At the time of submission, the information provided may be based on either preliminary findings or a completed investigation, depending on the status of the case.The submission of this report does not constitute an admission by carlsmed, its employees, or the u.S.Food and drug administration (fda) that the device, or carlsmed, caused or contributed to the event described.If relevant new information becomes available, the report will be updated accordingly, as required by regulatory obligations.

• Brand Name: APREVO
• Common Device Name: SPINAL INTERBODY INSERTER
• Manufacturer (Section D): CARLSMED, INC.; 1800 aston ave; ste 100; carlsbad CA 92008
• Manufacturer Contact: richard younger ; 1800 aston ave; ste 100; carlsbad, CA 92008
• MDR Report Key: 21149682
• Report Number: 3017936978-2025-00001
• Device Sequence Number: 9190331
• Product Code: MAX
• UDI-Device Identifier: 00810056991852
• UDI-Public: 00810056991852
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K241019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2025
• Device Catalogue Number: 1300
• Device Lot Number: CT-24-9154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female